DIAMICRON MR 30MG TABLETS

Transcript

S910 LEAFLET Diamicron 20170608

PACKAGE LEAFLET: INFORMATION FOR THE USER

DIAMICRON MR 30mg TABLETS
(gliclazide)
Your medicine is known as Diamicron MR 30mg Tablets but will be
referred to as Diamicron MR throughout the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
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Keep this leaflet. You may need to read it again.

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If you have any further questions, ask your doctor or
pharmacist.

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This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

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If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet
1. What Diamicron MR is and what it is used for

In most cases the symptoms of low blood sugar vanish very quickly
when you consume some form of sugar, for instance glucose
tablets, sugar cubes, sweet juice, sweetened tea. You should
therefore always carry some form of sugar with you (glucose
tablets, sugar cubes). Remember that artificial sweeteners are not
effective. Please contact your doctor or the nearest hospital if taking
sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or
develop very slowly or you are not aware in time that your blood
sugar level has dropped. This may happen if you are an elderly
patient taking certain medicines (for instance those acting on the
central nervous system and beta blockers). If you are in stresssituations (accidents, surgical operations, fever etc.) your doctor
may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when
gliclazide has not yet sufficiently reduced the blood sugar, when
you have not complied with the treatment plan prescribed by your
doctor, if you take St John’s Wort (Hypericum perforatum)
preparations (see section “Other medicines and Diamicron MR”) or
in special stress situations. These may include thirst, frequent
urination, dry mouth, dry itchy skin, skin infections and reduced
performance.

2. What you need to know before you take Diamicron MR
3. How to take Diamicron MR
4. Possible side effects

If these symptoms occur, you must contact your doctor or
pharmacist.

5. How to store Diamicron MR
6. Contents of the pack and other information
1. WHAT DIAMICRON MR IS AND WHAT IT IS USED FOR
Diamicron MR is a medicine that reduces blood sugar levels (oral
antidiabetic medicine belonging to the sulfonylurea group).
Diamicron MR is used in a certain form of diabetes (type 2 diabetes
mellitus) in adults, when diet, exercise and weight loss alone do not
have an adequate effect on keeping blood sugar at the correct
level.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DIAMICRON MR
Do not take Diamicron MR
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if you are allergic to gliclazide or any of the other ingredients of
Diamicron MR (listed in section 6), or to other medicines of the
same group (sulfonylureas), or to other related medicines
(hypoglycaemic sulfonamides),

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if you have insulin-dependent diabetes (type 1),

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if you have ketone bodies and sugar in your urine (this may
mean you have diabetic keto-acidosis), a diabetic pre-coma or
coma,

Blood glucose disturbance (low blood sugar and high blood sugar)
can occur when gliclazide is prescribed at the same time than
medicines belonging to a class of antibiotics called
fluoroquinolones, especially in elderly patients. In this case, your
doctor will remind you the importance of monitoring your blood
glucose.
If you have a family history of or know you have the hereditary
condition glucose-6-phosphate dehydrogenase (G6PD) deficiency
(abnormality of red blood cells), lowering of the haemoglobin level
and breakdown of red blood cells (haemolytic anaemia) can occur.
Contact your doctor before taking this medicinal product.
Children and adolescents
Diamicron MR is not recommended for use in children due to a lack
of data.
Other medicines and Diamicron MR
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened
and signs of low blood sugar levels may occur when one of the
following medicines is taken:
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other medicines used to treat high blood sugar (oral
antidiabetics, GLP-1 receptor inhibitors or insulin),

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antibiotics (sulfonamides, clarithromycin),

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medicines to treat high blood pressure or heart failure (beta
blockers, ACE-inhibitors such as captopril, or enalapril),

medicines to treat ulcers in the stomach or duodenum (H2
receptor antagonists),

During gliclazide treatment regular monitoring of your blood (and
possibly urine) sugar level and also your glycated haemoglobin
(HbA1c) is necessary.
In the first few weeks of treatment the risk of having reduced blood
sugar levels (hypoglycaemia) may be increased. So particularly
close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:

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medicines to treat depression (monoamine oxidase inhibitors),

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painkiller or antirheumatics (phenylbutazone, ibuprofen),

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medicines containing alcohol.

The blood glucose lowering effect of gliclazide may be weakened
and raised blood sugar levels may occur when one of the following
medicines is taken:
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medicines to treat disorders of the central nervous system
(chlorpromazine),

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if you take meals irregularly or skip meals altogether,

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medicines reducing inflammation (corticosteroids),

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if you are fasting,

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if you are malnourished,

medicines to treat asthma or used during labour (intravenous
salbutamol, ritodrine and terbutaline),

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if you change your diet,

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if you increase your physical activity and carbohydrate intake
does not match this increase,

if you suffer from particular hormone-induced disorders
(functional disorders of the thyroid gland, of the pituitary gland
or adrenal cortex),

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if your kidney function or liver function is severely decreased.

If you have low blood sugar you may have the following symptoms:
headache, intense hunger, nausea, vomiting, weariness, sleep
disorders, restlessness, aggressiveness, poor concentration,
reduced alertness and reaction time, depression, confusion, speech
or visual disorders, tremor, sensory disturbances, dizziness, and
helplessness.
The following signs and symptoms may also occur: sweating,
clammy skin, anxiety, fast or irregular heart beat, high blood
pressure, sudden strong pain in the chest that may radiate into
nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from
considerable confusion (delirium), develop convulsions, lose self
control, your breathing may be shallow and your heart beat slowed
down, you may become unconscious.

Blood glucose disturbance (low blood sugar and high blood sugar)
can occur when a medicine belonging to a class of antibiotics called
fluoroquinolones is taken at the same time than Diamicron MR
Tablets, especially in elderly patients.
Diamicron MR may increase the effects of medicines which reduce
blood clotting (warfarin).
Consult your doctor before you start taking another medicinal
product. If you go into hospital tell the medical staff you are taking
Diamicron MR.
Diamicron MR with food, drink and alcohol
Diamicron MR can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of
your diabetes in an unpredictable manner.
Pregnancy and breastfeeding
Diamicron MR is not recommended for use during pregnancy. If you
are pregnant, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine.
You must not take Diamicron MR while you are breastfeeding.

Driving and using machines
Your ability to concentrate or react may be impaired if your blood
sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if
you develop visual problems as a result of such conditions. Bear in
mind that you could endanger yourself or others (for instance when
driving a car or using machines). Please ask your doctor whether
you can drive a car if you:

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exceptionally, signs of severe hypersensitivity reactions
(DRESS) have been reported: initially as flu-like symptoms and
a rash on the face then an extended rash with a high
temperature.

Digestive disorders
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stomach pain or discomfort,

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feeling or being sick,

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indigestion,

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diarrhoea,

3. HOW TO TAKE DIAMICRON MR

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constipation.

Dose

These effects are reduced when Diamicron MR is taken with a
meal as recommended, See Section 3 “How to take”.

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have frequent episodes of low blood sugar (hypoglycaemia),

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have few or no warning signals of low blood sugar
(hypoglycaemia).

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The dose is determined by the doctor, depending on your blood and
possibly urine sugar levels.
Change in external factors (weight reduction, change in life style,
stress) or improvements in the blood sugar control may require
changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120
mg) in a single intake at breakfast time. This depends on the
response to treatment.
Diamicron MR is for oral use. Take your tablet(s) with a glass of
water at breakfast time (and preferably at the same time each day).
Swallow your tablets whole. Do not chew them.
You must always eat a meal after taking your tablet(s).
If a combination therapy of Diamicron MR with metformin, an alpha
glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4
inhibitor, a GLP-1 receptor agonist or insulin is initiated your doctor
will determine the proper dose of each medicine individually for you.
If you notice that your blood sugar levels are high although you are
taking the medicine as prescribed, you should contact your doctor
or pharmacist.
If you take more Diamicron MR than you should
If you take too many tablets, contact your doctor or the nearest
hospital Accident & Emergency department immediately. The signs
of overdose are those of low blood sugar (hypoglycaemia)
described in Section 2. The symptoms can be helped by taking
sugar (4 to 6 lumps) or sugary drinks straight away, followed by a
substantial snack or meal. If the patient is unconscious immediately
inform a doctor and call the emergency services. The same should
be done if somebody, for instance a child, has taken the product
unintentionally. Unconscious patients must not be given food or
drink.
It should be ensured that there is always a pre-informed person that
can call a doctor in case of emergency.

Eye disorders
Your vision may be affected for a short time especially at the start of
treatment. This effect is due to changes in blood sugar levels.
As for other sulfonylureas, the following adverse events have been
observed: cases of severe changes in the number of blood cells
and allergic inflammation of the wall of blood vessels, reduction in
blood sodium (hyponatraemia), symptoms of liver impairment (for
instance jaundice) which in most cases disappeared after
withdrawal of the sulfonylureas, but may lead to life-threatening liver
failure in isolated cases.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE DIAMICRON MR
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KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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Diamicron MR should be stored in the original package.

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Do not use after the expiry date printed on the carton label or
blister strip.

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If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

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If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

If you forget to take Diamicron MR
It is important to take your medicine every day as regular treatment
works better.
However, if you forget to take a dose of Diamicron MR, take the
next dose at the usual time. Do not take a double dose to make up
for a forgotten dose.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Diamicron MR contains
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If you stop taking Diamicron MR
As the treatment for diabetes is usually life long, you should discuss
with your doctor before stopping this medicinal product. Stopping
could cause high blood sugar (hyperglycaemia) which increases the
risk of developing complications of diabetes.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines this medicine can cause side effects, although
not everybody gets them.
The most commonly observed side effect is low blood sugar
(hypoglycaemia). For symptoms and signs see Section
"Warnings and precautions" in Section 2 “What you need to
know before you take".
If left untreated, these symptoms could progress to drowsiness, loss
of consciousness or possibly coma. If an episode of low blood
sugar is severe or prolonged, even if it is temporarily controlled by
eating sugar, you should seek immediate medical attention.

What Diamicron MR looks like and contents of the pack
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Diamicron MR are white oblong tablets marked ‘DIA 30’ on one
side and with a logo on the other.

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Diamicron MR Tablets are available as blister packs of 30 or 60
tablets.

Blood disorders
Decrease in the number of cells in the blood has been reported (for
instance platelets, red and white blood cells).This may cause:

POM

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paleness,

Leaflet revision date: 08 June 2017

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prolonged bleeding,

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bruising,

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sore throat,

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fever.

These symptoms usually vanish when the treatment is
discontinued.
Liver disorders
There have been isolated reports of abnormal liver function, which
can cause yellow skin and eyes. If you get this, see your doctor
immediately. The symptoms generally disappear if the medicine is
stopped. Your doctor will decide whether to stop your treatment.
Skin disorders
Skin reactions have been reported such as:
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rash,

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redness,

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itching,

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hives,

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angioedema (rapid swelling of tissues such as eyelids, face,
lips, mouth, tongue or throat that may result in breathing
difficulty). The rash may progress to widespread blistering or
peeling of the skin,

PL: 19488/0910

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leaflet in large print, tape, CD
or Braille.
Diamicron is a registered trade mark of Biofarma, France.
S910 LEAFLET Diamicron 20170608

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.